Sr Manager, Product Safety Risk Management - Medical Device
New
USFull-TimeManager
Salary145,806.8 - 218,710.2 USD per year
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Job Details
- Experience
- 8–10+ years
- Required Skills
- Risk Management
Requirements
- 8–10+ years of experience in medical devices or healthcare technology, with strong focus on product safety risk management in regulated environments.
- Deep expertise applying risk management principles aligned with ISO 14971 across software-based medical devices and full product lifecycles.
- Strong understanding of quality and regulatory frameworks including ISO 13485, IEC 62304, IEC 62366-1, and 21 CFR Part 820, EU MDR 2017/745, and Canadian medical device regulations.
- Proven ability to lead cross-functional decision-making and clearly communicate complex risk topics to senior stakeholders.
- Experience managing or developing teams within quality, regulatory, or product safety risk functions.
- Background working with Software as a Medical Device (SaMD), agile development, and cloud-based environments.
- Familiarity with tools such as Jira, Aha!, Xray Test Management, and Microsoft 365 is an advantage.
- Bachelor’s degree in engineering, computer science, life sciences, or related field (advanced certifications in risk management or regulatory affairs preferred).
Responsibilities
- Own and evolve the enterprise product safety risk management framework, ensuring consistent application across all programs and lifecycle stages.
- Define and maintain policies, procedures, tools, and governance structures aligned with risk-based quality system requirements.
- Lead safety risk strategy for complex medical imaging software programs, ensuring timely escalation, evaluation, and resolution of high-risk issues.
- Integrate risk management practices with design controls, software development lifecycles, usability engineering, cybersecurity risk management, and post-market surveillance.
- Oversee preparation, quality, and completeness of risk documentation, including hazard analyses, FMEAs, fault tree analyses, benefit-risk assessments, and Health Hazard Evaluations.
- Lead post-market safety activities including signal detection, CAPAs, and cross-functional response planning for emerging risks.
- Support regulatory submissions and product lifecycle documentation with robust safety risk inputs.
- Represent the organization in audits, inspections, and regulatory authority interactions, ensuring inspection readiness.
- Build, coach, and develop a high-performing risk management team while establishing performance metrics and continuous improvement practices.
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